This study is a randomized (1:1:1) comparative effectiveness trial of medication preference (zolpidem or trazodone), CBT-I, and the combination for the treatment of insomnia in 1200 men and women aged 18-80 years living in rural areas. Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information COZI will lead to answers for patients and providers addressing insomnia improved health and function for millions of rural Americans and sustainable changes in how insomnia is treated in rural practices. Patients and other stakeholders will also be part of the Steering Committee, which is the main decision-making group for our study, and which will meet monthly. Patients and other stakeholders have already provided guidance on which treatments are most worth studying, and which symptoms would best reflect the effects of treatment. SAC members will work with study investigators to recommend the best strategies for recruiting patients, measuring treatment effects, and disseminating study findings. Our study questions and design reflect early and ongoing engagement of key stakeholders including patients, providers, and payors, who are members of the Study Advisory Committee (SAC). The investigators will evaluate treatment effects at 9 weeks, and 6 and 12 months (with limited additional assessments for adverse events and medication use at 1 and 9 months). Patients will be treated with medication prescribed by their own physician (zolpidem or trazodone), Internet CBT-I, or a combination of the two. COZI will study 1200 patients (400 per treatment) recruited from 8 health care systems across the country, each of which has established practices in rural areas. 4: Conduct an exploratory analysis of heterogeneity of treatment effects for common factors (age, gender, socio-economic status, degree or rurality, and other factors). 3: Compare the side effects of medication preference, CBT-I, and combination treatment. 2: Compare the effectiveness of medication preference, CBT-I, and combination treatment for other symptoms and problems, including health-related quality of life, mood, and health outcomes. The aims of COZI are to: 1: Compare the effectiveness of medication preference (zolpidem or trazodone), CBT-I, and combination treatment for insomnia symptoms over 12 months. The investigators will use a well-tested Internet version of CBT-I, which is just as effective as in-person CBT-I, but more widely available. To address these questions, we propose the study, Comparative Effectiveness of Zolpidem/Trazodone and Cognitive Behavioral Therapy for Insomnia in Rural Adults (COZI). Patients, providers, and payors face important unanswered questions: Which treatment should be used for the treatment of chronic insomnia? Is combination therapy more effective, and does it result in lower zolpidem use? Who responds best to which treatment? These dilemmas are particularly relevant to patients and providers in rural areas, where access to behavioral health specialists is limited, and concerns regarding use of controlled substances is particularly acute. CBT-I is the recommended first line treatment by many professional organizations, but it is not widely available in physicians' practices. Trazodone is increasingly prescribed off-label for treatment of insomnia, but evidence of efficacy and safety is more limited. Zolpidem, the most frequently prescribed insomnia medication, is widely available, but may cause side effects and dependency. Medications and Cognitive-Behavioral therapy for insomnia (CBT-I a treatment program to improve sleep through changes in behavior and thinking) are both effective for treating insomnia. In developing this application, patients, providers, payors, and the investigators identified both concerns and opportunities with current treatments for chronic insomnia. Chronic insomnia is defined by problems with the quality or amount of sleep, including difficulty falling asleep, frequent awakenings, and/or awakening early and being unable to return to sleep. Insomnia is a common health problem that causes distress, impaired function, and increased risk for other health problems. Why Should I Register and Submit Results?.
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